(2003; 15 pages)
PHENYLPROPAN-OLAMINE - New warnings on cardiovascular risks to be added
Japan. The Ministry of Health, Labour and Welfare (MHLW) has asked manufacturers of products containing phenylpropanolamine (PPA) to include new warnings on cardiovascular risks. The move follows several reports of cerebral haemorrhage and other problems associated with the use of PPA containing products. Around 170 products, mostly OTC cough and cold preparations containing PPA, are available in Japan. Although a US study published in 2000 suggested a link between PPA and haemorrhagic stroke, the Japanese government did not impose use restrictions at the time since the US study observations were based on a much higher dose (150 mg) used in appetite suppressants and diet aids compared with the more conservative maximum daily dose of 100 mg in the OTC preparations in Japan; appetite suppressants are not approved in Japan. The PPA products in Japan already carry warnings about the potential risk in people with a history of high blood pressure or other cardiovascular problems. Despite these, there have been several adverse drug reaction reports necessitating the current move by MHLW to include stricter warnings on possible side effects, including cerebral haemorrhage. The MHLW has not restricted sales but is encouraging manufacturers to develop non-PPA products. (Also see WHO Pharmaceuticals Newsletter No. 4, 1996).
Scrip World Pharmaceutical News No. 2876, 15 Aug 2003.